Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02013466
Status:
COMPLETED
Last Update Posted:
2013-12-17
First Post:
2013-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-11', 'studyFirstSubmitDate': '2013-12-02', 'studyFirstSubmitQcDate': '2013-12-11', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome parameter in this study is the Maximum serum leucine concentration (Leumax) [micromol/L].', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}], 'secondaryOutcomes': [{'measure': 'Serum leucine incremental area under the curve (iAUC) [micromol/L*min].', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Time to reach half the serum leucine iAUC (t½) [minutes].', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Maximum serum essential amino acid concentration (EAAmax) [micromol/L]', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Maximum serum amino acid concentration (AAmax) [mmol/L]', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Maximum serum insulin concentration [micromol/L].', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Serum insulin iAUC [micromol/L*min]', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Maximum serum glucose concentration [mmol/L]', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Serum glucose iAUC [mmol/L*min]', 'timeFrame': 'Up to 4 hours after each bolus intake (4 visits, 7-10 days between 2 consecutive visits)'}, {'measure': 'Adverse events and (Gastro-Intestinal) tolerance questionnaire.', 'timeFrame': 'During the study and until one week after completion of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioavailability', 'Amino Acids', 'Elderly', 'Supplement'], 'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '25790724', 'type': 'DERIVED', 'citation': 'Luiking YC, Abrahamse E, Ludwig T, Boirie Y, Verlaan S. Protein type and caloric density of protein supplements modulate postprandial amino acid profile through changes in gastrointestinal behaviour: A randomized trial. Clin Nutr. 2016 Feb;35(1):48-58. doi: 10.1016/j.clnu.2015.02.013. Epub 2015 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'In this study healthy older adults are requested to consume 4 different high-protein nutritional supplements. Each subject will visit the site 4 times and at every visit they will consume 1 of the 4 products after which a series of blood samples will be taken. The blood samples will be analyzed for amino acid bioavailability in the blood up to 4 hours after consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 65 years or older\n* BMI between 21 and 30 kg/m2\n\nExclusion Criteria:\n\n* Any condition that may interfere with the definition 'healthy elderly' according to the investigator's judgement.\n* Any (history of) gastrointestinal disease that interferes with GI function (e.g. inflammatory bowel disease, gastroparesis, gastrectomy).\n* Known allergy to milk and milk products.\n* Known galactosaemia.\n* Current or recent (within past three months) smoking.\n* Known or suspected Diabetes Mellitus.\n* Current infection or fever in the last 7 days at the discretion of the physician.\n* Use of antibiotics within 3 weeks of study entry.\n* Current use of corticosteroids or hormones.\n* Current use of antacids or any medication influencing gastric acid production.\n* Requirement for any nutritional support.\n* Unplanned body weight loss \\> 5% in the past 3-6 months.\n* Adherence to any specific diet (e.g. weight loss, vegetarian).\n* Use of protein containing or amino acid containing nutritional supplements within one week of study entry.\n* Alcohol or drug abuse.\n* Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements.\n* Participation in any other study with investigational products concomitantly or within 4 weeks of study entry."}, 'identificationModule': {'nctId': 'NCT02013466', 'acronym': 'ArenA', 'briefTitle': 'Amino Acid Bioavailability in Healthy Elderly After Intake of an Oral Nutritional Supplement', 'organization': {'class': 'INDUSTRY', 'fullName': 'Nutricia Research'}, 'officialTitle': 'Amino Acid Bioavailability in Healthy Elderly After Bolus Intake of a High Whey-protein, Leucine-rich, Low-caloric Oral Nutritional Supplement', 'orgStudyIdInfo': {'id': 'Sip.1.C/B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Bolus ONS intake', 'description': 'Bolus ONS A Bolus ONS B Bolus ONS C Bolus ONS D ONS = oral nutritional supplement 4-way cross-over design: Determination of the product order is based on a Latin square design. 3 Latin squares (4x4) are used, resulting in 12 unique product orders. Subjects receive a randomisation number corresponding with 1 of the 12 product orders. Study product labels will contain randomisation number and appropriate visit number.', 'interventionNames': ['Dietary Supplement: Bolus ONS A', 'Dietary Supplement: Bolus ONS B', 'Dietary Supplement: Bolus ONS C', 'Dietary Supplement: Bolus ONS D']}], 'interventions': [{'name': 'Bolus ONS A', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High-whey protein, leucine-rich, low-caloric ONS in powder format', 'armGroupLabels': ['Bolus ONS intake']}, {'name': 'Bolus ONS B', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High casein-protein, low-caloric control product (isocaloric to product A)', 'armGroupLabels': ['Bolus ONS intake']}, {'name': 'Bolus ONS C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'High casein-protein, high-caloric control product.', 'armGroupLabels': ['Bolus ONS intake']}, {'name': 'Bolus ONS D', 'type': 'DIETARY_SUPPLEMENT', 'description': 'high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)', 'armGroupLabels': ['Bolus ONS intake']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Ampha', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}